CN101455715B - Suppository for treating gynecologic diseases and preparation method thereof - Google Patents
Suppository for treating gynecologic diseases and preparation method thereof Download PDFInfo
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Abstract
The invention relates to a suppository for treating gynecopathy and preparation method thereof. The suppository is obtained by the steps of processing raw materials and auxiliary materials such as sophora root, pearl layer powder, dried alum, quassia wood, cnidium seed, berbamine hydrochloride, menthol, borneol, boracic acid, seabuckthorm seed oil, and mixed fatty glyceride. Compared with present technology, the inventions has better curative effect, nonirritant, and no toxicity and side effect mainly and the invention is applied to treatment for vaginitis, cervicitis and cervical erosion having good effectiveness and high curative rate.
Description
Technical field
The present invention relates to a kind of Chinese medicine preparation for the treatment of vaginitis, cervicitis, cervical erosion and preparation method thereof, belong to technical field of traditional Chinese medicine pharmacy.
Technical background
Vaginitis, cervicitis, cervical erosion are common gynecological disease, frequently-occurring disease.From various gynaecopathia reconnaissance informations, the women who suffers from various vaginitiss and cervicitis accounts for 2/3rds, because women's special physiological characteristics have caused gynopathic multiple, crypticity and intractable have seriously influenced women's quality of life and physical and mental health.
In the prior art, the clinical practice of FUYANPING preparation has obtained certain effect for many years, the use inconvenience but FUYANPING is loose, and FUYANPING SHUAN (external) capsule shells is dissolved slowly; The foam that the FUYANPING effervescent tablet produces has increased contacting of medicine and agents area, but owing to including a large amount of soda acid effervescents, during use mucosa is easily produced zest, and be difficult for being absorbed by the body.The Chinese patent communique disclosed application number on July 31st, 2002 and has been: 00136924.5, name is called " a kind of nanometer FUYANPING preparation medicine and preparation method thereof ", and nanotechnology at present almost can not be implemented in herbal pharmaceutical technology (pulverizing medicinal materials to particle diameter is 0.1-200nm).On January 12nd, 2005 disclosed application number and is: 200410017292.6, and name is called " FUYANPING soft capsule and preparation method thereof ", and it is an oral formulations, and onset is slow, and adjuvant is many, and curative effect is general.On February 15th, 2006 disclosed application number and is: 200510032089.0, and name is called " liquor for eliminating gynecological inflammation and preparation method thereof ", and it is external-use lotion, uses inconvenience, and is difficult for preserving unsatisfactory curative effect.On March 15th, 2006 disclosed application number and is: 200410046738.8, and it is coarse that name is called " a kind of FUYANPING preparation and preparation method thereof " its research, and it is 15.38g that specific embodiment 2 is made every of effervescent tablet by its technology, does not meet reality.
The Chinese patent communique disclosed application number on January 5th, 2005 and has been: 200410022962.3, name is called " FUYANPING SHUAN and preparation method " in application process, we find that effect is not ideal enough, and mucosal tissue is had stronger zest, and suppository melts and becomes the time limit and be subject to seasonal effect.
The applicant is in order to solve the existing in prior technology defective, by excavating the abundant natural resources of Chinese medicinal materials of motherland, in conjunction with a large amount of traditional Chinese medical science prescription theory and Study on clinical pharmacodynamics, elite suppository is most preferred dosage form, disclosing application number on January 5th, 2005 at the Chinese patent communique is: 200410022962.3, name is called " FUYANPING SHUAN and preparation method " and invents existing defective, in the time in recent years, we are on original basis, grope by a large amount of experiments, after it is unexpected that discovery add an amount of Fructrs Hippophae seed oil, can avoid its zest fully to the vaginal mucosa tissue, to the enhancing evident in efficacy of vaginitis and cervicitis, and cervical erosion also there is good therapeutical effect; Its cure rate to gynaecopathia significantly improves, and has received beyond thought effect.
Up to now, put down in writing the concrete proportioning raw materials relation of medicine under the present invention without any report, also nobody disclosed and selects the made medicine of proportioning raw materials relation of the present invention to have beat all therapeutic effect.
Summary of the invention
The purpose of this invention is to provide a kind of curative effect and treat Chinese medicine preparation of vaginitis, cervicitis and preparation method thereof more significantly, and without any side effects.
The present invention is achieved in that to make this pharmaceutical composition raw materials of effective components as follows: Radix Sophorae Flavescentis 500g, Margarita layer powder 5g, dried Alumen 100g, Ramulus Et Folium Picrasmae 400g, Fructus Cnidii 400g, berberine hydrochloride 40g, Mentholum 4g, Borneolum Syntheticum 10g, boric acid 60g, Fructrs Hippophae seed oil 250ml, mixed fatty glycerides 1200g.Described Chinese medicine preparation is a suppository.
Pharmacodynamic test of active extract proves:
Suppository group of the present invention: suppository raw material weight proportioning of the present invention is: Radix Sophorae Flavescentis 500g, Margarita layer powder 5g, dried Alumen 100g, Ramulus Et Folium Picrasmae 400g, Fructus Cnidii 400g, berberine hydrochloride 40g, Mentholum 4g, Borneolum Syntheticum 10g, boric acid 60g, Fructrs Hippophae seed oil 250ml, mixed fatty glycerides 1200g.
The FUYANPING SHUAN group, (application number is: 200410022962.3, name is called " FUYANPING SHUAN and preparation method ") group is by Radix Sophorae Flavescentis 500g, Margarita layer powder 5g, dried Alumen 100g, Ramulus Et Folium Picrasmae 400g, Fructus Cnidii 400g, berberine hydrochloride 40g, Mentholum 4g, Borneolum Syntheticum 10g, boric acid 60g, substrate (stearic acid, semi-synthetic fatty acid ester, vaseline, liquid Paraffin, tween-80, lecithin, glycerol, gelatin, Polyethylene Glycol, ethyl p-hydroxybenzoate) in right amount.
Conclusion: suppository group of the present invention is compared the pharmacodynamic experiment result with the FUYANPING SHUAN group and is significantly increased.
Pharmacodynamic test of active extract:
Experimental drug
1, suppository group of the present invention
Suppository group raw material of the present invention: Radix Sophorae Flavescentis 500g, Margarita layer powder 5g, dried Alumen 100g, Ramulus Et Folium Picrasmae 400g, Fructus Cnidii 400g, berberine hydrochloride 40g, Mentholum 4g, Borneolum Syntheticum 10g, boric acid 60g, Fructrs Hippophae seed oil 250ml, mixed fatty glycerides 1200g.
Suppository technology of the present invention: get Margarita layer powder, berberine hydrochloride, dried Alumen, boric acid and be ground into fine powder, sieve, standby.Other gets Fructus Cnidii and is ground into fine powder, crosses 100 mesh sieves, and is standby.Radix Sophorae Flavescentis, Ramulus Et Folium Picrasmae branch are added each secondaries of 80% alcohol heating reflux of 6 times of amounts, each 2 hours, filter merging filtrate, decompression recycling ethanol (0.08Mpa, 65～70 ℃) filtrate is concentrated into relative density 1.17-1.21 (60 ℃), and drying is ground into fine powder, add above-mentioned fine powder, mix homogeneously sieves.Borneolum Syntheticum, Mentholum are ground into fine powder are dissolved in mixing in the Fructrs Hippophae seed oil, standby.The mixed fatty glycerides heating is made fusing, filter, behind the Fructrs Hippophae seed oil mixing, in 40-50 ℃ of insulation, add medicated powder, mixing makes 1000 of bolt grains.
2, FUYANPING SHUAN group
FUYANPING SHUAN group raw material: Radix Sophorae Flavescentis 500g, Margarita layer powder 5g, dried Alumen 100g, Ramulus Et Folium Picrasmae 400g, Fructus Cnidii 400g, berberine hydrochloride 40g, Mentholum 4g, Borneolum Syntheticum 10g, boric acid 60g, substrate (stearic acid, semi-synthetic fatty acid ester, vaseline, liquid Paraffin, tween-80, lecithin, glycerol, gelatin, Polyethylene Glycol, ethyl p-hydroxybenzoate) are in right amount.
FUYANPING SHUAN group technology:
Get Radix Sophorae Flavescentis, Ramulus Et Folium Picrasmae and Fructus Cnidii and be ground into coarse powder and add 80% ethanol percolation or reflux and concentrate, spray drying, the powder that gets dry extract is standby; Margarita layer powder, berberine hydrochloride, dried Alumen, boric acid, Borneolum Syntheticum, Mentholum are ground into fine powder, and be standby with above-mentioned dried cream powder mixing; Other gets, and substrate is an amount of, and heating is dissolved, and temperature is reduced to about 50 ℃, adds above-mentioned medicated powder, stirs evenly, and injects the suppository mould, waits to solidify the back and takes out, and packing both got.
Test method and result
One, antiinflammatory action
1, the influence of xylol induced mice auricle edema
50 of the female Kunming mouses of healthy adult, body weight 18～22g is divided into 5 groups at random, 10 every group.Matched group is given the equivalent normal saline; FUYANPING SHUAN group administration daily dose is 0.64g crude drug/kg; Suppository group of the present invention administration little, in, big daily dose is respectively 0.16,0.32,0.64g crude drug/kg.Vagina administration, every day 2 times, each 6h at interval, successive administration 7d.Behind last administration 30min, be coated with dimethylbenzene 0.5ml in the mouse right ear same area, left side ear is not done any processing, put to death mice with marrow-breaking behind the 30min, draw materials in the punching of mice left and right sides auricle same area with diameter 6mm card punch, weigh, as the swelling degree, and obtain suppression ratio with two auricle weight differences.See Table 1
The influence of swelling due to the table 1 pair Mice Auricle dimethylbenzene (x ± s)
Compare * * P＜0.01 with matched group; With the FUYANPING SHUAN group than △ P＜0.05, #P 0.05.
The result: suppository group of the present invention and FUYANPING SHUAN group xylol induced mice auricle edema have the obvious suppression effect, have compared significant difference with matched group.Suppository group of the present invention is stronger than FUYANPING SHUAN group antiinflammatory action.
2, to the influence of the swollen weight of rat granuloma
50 of healthy adult SD female rats, body weight 200～220g is divided into 5 groups at random, 10 every group.Etherization is implanted 20mg sterilization dry cotton ball, skin suture, every intramuscular injection 50,000 unit penicillins at aseptic condition bottom left ventral groove place.Difference vagina administration, matched group are given and are composed the row bolt; FUYANPING SHUAN group administration daily dose is 0.32g crude drug/kg; Suppository group of the present invention administration little, in, big daily dose is respectively 0.08,0.16,0.32g crude drug/kg.The same day vagina administration, administration every day 2 times, each 6h at interval, 7d continuously, 8d puts to death and takes out cotton balls, claims weight in wet base with each cotton balls, is positioned over after weighing to claim dry weight (granulomatous weight=weight in wet base-dry weight) after putting into 70 ℃ of baking oven 2h in the enamel tray.See Table 2
The influence of the swollen weight of table 2 pair rat granuloma (x ± s)
Compare * * P＜0.01 with matched group; With the FUYANPING SHUAN group than △ P＜0.05, #P 0.05.
The result: suppository group of the present invention and FUYANPING SHUAN group have significant inhibitory effect to the mice granuloma due to the embedding cotton balls, have compared significant difference with matched group.Suppository group of the present invention is stronger than the antiinflammatory action of FUYANPING SHUAN group.
3, the influence of the rat paw edema that causes of on Carrageenan
50 of healthy adult SD female rats, body weight 200～220g is divided into 5 groups at random, 10 every group.Matched group is given the equivalent normal saline; FUYANPING SHUAN group dosage is 0.32g crude drug/kg; Suppository group of the present invention administration little, in, heavy dose is respectively 0.08,0.16,0.32g crude drug/kg.Respectively organize the right sufficient sole of the foot thickness of rat with the caliper-gauge measurement before the experiment, only smear administration 0.2ml/ then, behind the administration 1h, the right sufficient sole of the foot subcutaneous injection 0.5% freshly prepared carrageenin 0.1ml/ of portion only causes inflammation rat, the repaste medicine is 1 time simultaneously, later on every 1h coating 1 time, measure the thickness that causes scorching back 1h, 2h, 3h, the right sufficient sole of the foot of 4h rat, measure the swelling degree.(thickness before the thickness after swelling degree=the cause inflammation-cause is scorching) sees Table 3
The influence of the rat paw edema that table 3 on Carrageenan causes (x ± s)
Compare * * P＜0.01 with matched group; With the FUYANPING SHUAN group than △ P＜0.05, #P 0.05.
The result: suppository group of the present invention and FUYANPING SHUAN group all had the effect of remarkable minimizing pedal swelling since 2 hours, the rat paw edema that on Carrageenan causes has significant antagonism, has compared significant difference with matched group.Suppository group of the present invention is stronger than the antiinflammatory action of FUYANPING SHUAN group.
Two, analgesic activity
50 of healthy adult Kunming female mices, body weight 18～22g is divided into 5 groups at random, 10 every group.Matched group is given the equivalent normal saline; It is 0.64g crude drug/kg that the FUYANPING SHUAN group is given a day pharmaceutical quantities; Suppository group of the present invention administration little, in, big daily dose is respectively 0.16,0.32,0.64g crude drug/kg.Vagina administration, every day 2 times, each 6h at interval, successive administration 7d.Behind last administration 2h, every equal lumbar injection 0.6% acetic acid 0.2ml of mice, mouse writhing number of times and suppression ratio in the record 20min.
See Table 4
The influence of table 4 Dichlorodiphenyl Acetate induced mice writhing response (x ± s)
Compare * * P＜0.01 with matched group; With the FUYANPING SHUAN group than △ P＜0.05, #P 0.05.
The result: suppository group of the present invention and FUYANPING SHUAN group can make the mouse writhing number of times reduce, and dose-effect reaction relation is preferably arranged, and along with the increasing of dosage, turn round the body number of times and reduce, and it is inhibited that the Dichlorodiphenyl Acetate induced mice is turned round body, compares the difference that significance is arranged with matched group.Suppository group of the present invention is stronger than the analgesic activity of FUYANPING SHUAN group.
Three, histamine phosphate is caused the influence of the reaction of itching
50 of Cavia porcelluss, body weight 240～300g, male and female half and half are divided into 5 groups at random, and 10 every group, matched group is given the equivalent normal saline; FUYANPING SHUAN group dosage is 0.30g crude drug/kg; Suppository group of the present invention administration little, in, heavy dose is respectively 0.08,0.15,0.30g crude drug/kg.The experiment proxima luce (prox. luc) is shaved hair and coating 1 time to each group Cavia porcellus right back instep, 0.2ml/ only, experiment is shaved hair place, the about 1cm of area when daily coarse sandpaper abrades right back instep
2, repaste medicine 1 time, 10min behind the coating by 0.05mL/ only drips 0.01% phosphoric acid tissue at Cavia porcellus wound surface place, comply with 0.01%, 0.02%, 0.03% every 3min later on ... progressive concentration.Only being 0.05mL/ at every turn, later licking right back instep until Cavia porcellus occurring, is itch-threshold with the histamine phosphate's total amount that occurs at last being given when Cavia porcellus later licks right back instep.See Table 5
Table 5 pair histamine phosphate causes the influence (x ± s) of the reaction of itching
Compare * * P＜0.01 with matched group; With the FUYANPING SHUAN group than △ P＜0.05, #P 0.05.
The result: suppository group of the present invention and FUYANPING SHUAN group can significantly improve the itch-threshold that histamine phosphate causes the reaction of itching, and compare the difference that significance is arranged with matched group.Suppository group of the present invention strengthens than FUYANPING SHUAN group itching-relieving action.
Four, microcirculation of mouse auricle is influenced
50 of healthy adult Kunming female mices, body weight 18～22g is divided into 5 groups at random, 10 every group.Matched group is given the equivalent normal saline; FUYANPING SHUAN group dosage is 0.64g crude drug/kg; Suppository group of the present invention administration little, in, heavy dose is respectively 0.16,0.32,0.64g crude drug/kg.Mouse peritoneal injection urethane 1.8g/kg anesthesia back is auricle fixedly, amplifies 80 times under microcirculation microscope, is the object of observation with the set blood capillary, observes the variation of caliber, and caliber is measured with eyepiece micrometer.Respectively organize intraperitoneal injection then, 0.2ml/ only measures the variation of caliber behind administration 5,10,20, the 30min, each time caliber rate of change after the calculating administration.Caliber rate of change=(the preceding value of the preceding value/medicine of value-medicine behind the medicine) sees Table 6
Table 6 pair microcirculation of mouse auricle influence (x ± s)
Compare * * P＜0.01 with matched group; With the FUYANPING SHUAN group than △ P＜0.05, #P 0.05.
The result: suppository group of the present invention and FUYANPING SHUAN group can obviously reduce dwindling of caliber, and the effect of expansion caliber is compared variant with matched group.Suppository group of the present invention is stronger than the effect of FUYANPING SHUAN group microcirculation improvement.
Five, to the influence of experimental inflammation of uterus
50 of healthy adult SD female rats, body weight 200～220g, no pregnant, be divided into 5 groups at random, 10 every group, matched group is given the equivalent normal saline; FUYANPING SHUAN group dosage is 0.32g crude drug/kg; Suppository group of the present invention administration little, in, heavy dose is respectively 0.08,0.16,0.32g crude drug/kg.Rat is slightly anaesthetized with ether, cut off the hypogastric region hair, 75% ethanol disinfection is in hypogastric region median incision 2cm, expose the uterus, make a transverse incision along 1cm place on the cornua uteri of left side, with a caliber 2mm, long 0.5cm, the sterilization plastic tube of heavily about 2mg places intrauterine and myometrial suture to fix, prevent to come off, the wound splashes into 1 of gentamycin sulfate, in case infect.Sew up inside and outside stomach wall then, the sterilization wound, postoperative 2h begins vagina administration, administration every day 2 times, each 6h at interval, 7d puts to death animal in 8d continuously, takes out two Aconitum carmichaeli Debx. palaces and weighs respectively, calculates inflammation swelling degree.(inflammation swelling degree=uterus, weight-right side, uterus, left side is heavy).See Table 7
The influence of table 7 pair experimental inflammation of uterus (x ± s)
Compare * * P＜0.01 with matched group; With the FUYANPING SHUAN group than △ P＜0.05, #P 0.05.
The result: suppository group of the present invention and FUYANPING SHUAN group have the obvious suppression effect to rat experiment temper cervicitis disease, compare the difference that significance is arranged with matched group.Suppository group of the present invention is stronger to the effect that inflammation of uterus suppresses than FUYANPING SHUAN group.
Six, extracorporeal bacteria inhibitor test
1, the preparation of test sample:
FUYANPING SHUAN and FUYANPING SHUAN are diluted to suspension with 20% dimethyl sulfoxide with 1:4 respectively.
2, staphylococcus aureus, escherichia coli, Candida albicans, pseudomonas aeruginosa cultural method:
Get some sterilization test tube with ground stoppers, each adds aseptic MH meat soup 4.5ml, under aseptic condition, draws 4.5ml test sample suspension respectively, adds first test tube, fully mixing.Draw 4.5ml then and add in second test tube, two-fold dilution like this is pipe second from the bottom extremely, and discards 4.5ml, and last pipe is made blank.Every pipe adds 0.5ml10
6The fresh bacterium liquid of CFU/ml, in 37 ℃ of cultivation 18h, observation has or not bacterial growth.Other establishes pipe culture medium (5ml) contrast, cultivates under similarity condition.Contained drug concentration is minimal inhibitory concentration (MIC) in the test tube of no bacterial growth.
2, Bacillus subtillis cultural method:
Get some sterilization test tube with ground stoppers, each adds aseptic MH meat soup 4.5ml, under aseptic condition, draws 4.5ml test sample suspension respectively, adds first test tube, fully mixing.Draw 4.5ml then and add in second test tube, two-fold dilution like this is pipe second from the bottom extremely, and discards 4.5ml, and last pipe is made blank.Every pipe adds 0.5ml10
6The fresh bacterium liquid of cfu/ml, in 37 ℃ of cultivations 24h, 48h, 72h, observation has or not bacterial growth.Other establishes pipe culture medium (5ml) contrast, cultivates under similarity condition.The final bacterial growth situation of record 72h.Contained drug concentration is minimal inhibitory concentration (MIC) in the test tube of no bacterial growth.See Table 8,9
Table 8 suppository of the present invention is to antibacterial MIC measurement result
Table 9 FUYANPING SHUAN is to antibacterial MIC measurement result
The result: suppository group of the present invention is respectively 1/80,1/40,1/40,1/20,1/10 to staphylococcus aureus, escherichia coli, Candida albicans, pseudomonas aeruginosa, Bacillus subtillis minimal inhibitory concentration (MIC).The FUYANPING SHUAN group is respectively 1/40,1/40,1/20,1/10,1/10 to the minimal inhibitory concentration (MIC) of five kinds of bacterium.Suppository group of the present invention is stronger to staphylococcus aureus, escherichia coli, Candida albicans, pseudomonas aeruginosa, Bacillus subtillis bacteriostasis than FUYANPING SHUAN group.
Seven, to the experimental treatment of rabbit bacterial vaginitis
48 of the female unpregnancy rabbit of healthy adult, body weight 1.8～2.2kg is divided into 6 groups at random, 8 every group.Experimental strain staphylococcus aureus, escherichia coli, pseudomonas aeruginosa are recovered, gone down to posterity, be mixed with 10 with physiological saline solution
6CFU/ml bacterium liquid is mixed into infectious bacteria liquid in the ratio of 1:1:1 with three kinds of bacterium liquid.Earlier with aseptic 0.01ML/LPBS (pH8.5) flushing rabbit vagina 3 times, each interval 5min dips in aseptic cotton swab then and gets infectious bacteria liquid and embrocate rabbit vagina 1～2min repeatedly, the next day repaste once.Day by day observe the rabbit vaginosis behind the inoculated bacteria and become situation, and get vaginal secretions smear staining microscopy.Obviously congested, red and swollen and when the rabbit vagina with a large amount of purulent secretions, get the secretions smear, when visible down a large amount of infectious bacteria of mirror and non-viable non-apoptotic cell, rabbit bacterial vaginitis model prepares successfully.12d all presents the vaginitis symptom behind 40 experimental rabbits inoculated bacterias.The difference vagina administration, model group is composed capable agent vaginal suppository; Suppository group administration daily dose of the present invention is 0.16g crude drug/kg; Suppository group of the present invention administration little, in, big daily dose is respectively 0.04,0.08,0.16g crude drug/kg; Normal control group rabbit is inoculated bacteria not, composes capable bolt.Every day 2 times, each 6h at interval, 7d continuously.7d vagina pathological changes situation after the administration of observed and recorded infection animal.Get vaginal swab smear staining microscopy, rabbit is got vagina tissue after living and killing, with freshly prepared 3.6% formaldehyde fixed, paraffin embedding, pathological section, and HE dyeing, microscopy.See Table 10
Criterion
Recovery from illness: the vagina outward appearance does not have hyperemia, redness, no purulent secretion, and the vaginal swab smear for microscopic examination does not have infectious bacteria and non-viable non-apoptotic cell, and tissue slice medial vagina mucosa is complete, and submucous tissue is normal substantially.
Take a turn for the better: the vagina outward appearance has mild hyperaemia, redness, a small amount of purulent secretion is arranged, the visible a small amount of infectious bacteria of vaginal swab smear for microscopic examination and a small amount of non-viable non-apoptotic cell, the visible vaginal mucosa of vagina tissue section microscopy has slight damaged, telangiectasis in the submucous tissue, erythrocytosis have a small amount of neutrophil infiltration in the tissue.
Invalid: the hyperemia of vagina outward appearance, redness, a large amount of purulent secretions are arranged, visible a large amount of infectious bacterias of vaginal swab smear for microscopic examination and non-viable non-apoptotic cell, the visible vaginal mucosa of vagina tissue section microscopy has damaged, a large amount of telangiectasis, erythrocytosis have a large amount of neutrophil infiltration in the submucous tissue in the tissue.
The table 10 pair experimental therapeutic outcome of rabbit bacterial vaginitis
The result: suppository group of the present invention is respectively 75.0%, 87.5%, 100% to the effective percentage of the rabbit bacterial vaginitis treatment that staphylococcus aureus, escherichia coli, pseudomonas aeruginosa mixed infection cause, the effective percentage of FUYANPING SHUAN group treatment is 75.0%.Suppository group of the present invention is than FUYANPING SHUAN group effective to rabbit bacterial vaginitis treatment.
Eight, the effect of the mice subcutaneous abscess model that trichomonal vaginitis is caused
120 of healthy adult kunming mices, male and female half and half, body weight 18～22g is divided into 6 groups at random, 20 every group.The normal control group is all used the infusorian suspension with the normal saline of sterilization, all animals of other each group, and it is subcutaneous to cut left side, plucked back only to be injected in mice by 0.2ml/, measures the size of skin bubble, observes 72h.When the local skin inspection, inflammatory reaction and subcutaneous lumps such as redness appear, show that experimental animal model sets up successfully, behind 100 mouse inoculation antibacterial 72h, model prepares successfully.Normal control group, the model group sterilization starch solution that contains tween 80; FUYANPING SHUAN group dosage is 0.64g crude drug/kg; Suppository group of the present invention administration little, in, heavy dose is respectively 0.16,0.32,0.64g crude drug/kg.Use the cotton swab method, smear inoculation position skin, every day 1 time, successive administration 7d.Put to death all laboratory animals after 8d weighs, the abscess size is measured at perusal subcutaneous abscess position, detects in the abscess whether active infusorian is arranged, Ji's nurse Sa dyeing microscopic examination.Detect internal organs such as intraperitoneal, liver, spleen simultaneously and have or not infusorian property abscess, win the subcutaneous abscess specimen, with freshly prepared 3.6% formaldehyde fixed, paraffin embedding, pathological section, HE dyeing, microscopy.See Table 11
Criterion
Recovery from illness: skin appearance does not have hyperemia, redness, dissects the no subcutaneous abscess in back, and internal organs such as intraperitoneal, liver, spleen do not have infusorian property abscess.
Take a turn for the better: skin appearance has slight hyperemia, redness, and few subcutaneous abscess is arranged after the dissection, and internal organs such as intraperitoneal, liver, spleen do not have infusorian property abscess.Visible caseous necrosis tissue in the abscess tissue slice, the visible dead infusorian of smear, inert infusorian.
Invalid: skin appearance has hyperemia, redness, and subcutaneous abscess is arranged after the dissection, and internal organs such as intraperitoneal, liver, spleen have or do not have infusorian property abscess.Visible caseous necrosis tissue and infusorian in the abscess tissue slice, smear visible dead infusorian and active infusorian.Telangiectasis is arranged in the submucous tissue, a large amount of neutrophilic granulocytes and macrophages infiltration are arranged in the tissue.
The influence of the mice subcutaneous abscess that table 11 pair trichomonal vaginitis causes
The result: suppository group of the present invention and FUYANPING SHUAN group are inhibited to the mice subcutaneous abscess that trichomonal vaginitis causes, along with dosage increases, it strengthens the abscess inhibitory action.Suppository group of the present invention is stronger to the antibacterial action of trichomonal vaginitis than FUYANPING SHUAN group.
Nine, the rabbit experiment vaginitis effect that Candida albicans is caused
48 of the female unpregnancy rabbit of healthy adult, body weight 1.8～2.2kg is divided into 6 groups at random, 8 every group.All animals are all used the normal saline flushing vagina 3 times, each 5min at interval, the normal saline of normal control group selection sterilization, other each treated animal is all selected the Candida albicans suspension, smears rabbit vagina 1～2min repeatedly with cotton swab, the next day repaste once continue 5d.The vagina toposcopy, inflammatory reaction appears, secretions increases or occurs the purulent secretion of white bulk or wire drawing shape, get the vaginal secretions smear with cotton swab, the Gram's staining microscopy, when visible down a large amount of infectious bacteria of mirror and non-viable non-apoptotic cell, the colpitis mycotica modelling of Candida albicans success like this.5d all presents the vaginitis symptom behind 40 experimental rabbits inoculated bacterias.The difference vagina administration, normal control group, model group are composed capable bolt; FUYANPING SHUAN group administration daily dose is 0.16g crude drug/kg; Suppository group of the present invention administration little, in, big daily dose is respectively 0.04,0.08,0.16g crude drug/kg.Every day 2 times, each 6h at interval, successive administration 7d.After weighing, 8d puts to death all laboratory animals, the reaction of perusal colpitis and secretions situation and smear, Gram's staining microscopy.Win animal vagina specimen, with freshly prepared 3.6% formaldehyde fixed, paraffin embedding, pathological section, HE dyeing, microscopy.See Table 12
Criterion
Recovery from illness: vaginal mucosa does not have hyperemia, redness, smooth surface, does not have the purulent secretion of white bean curd slag specimen and wire drawing shape, and the vaginal smear microscopy does not have Candida albicans and exfoliative cyte, and the visible mucosa of tissue slice is complete, and submucous tissue is normal.
Take a turn for the better: vaginal mucosa has mild hyperaemia, redness, surperficial little rough, the purulent secretion of a small amount of white bean curd slag specimen and wire drawing shape, visible a small amount of Candida albicans of vaginal smear microscopy and exfoliative cyte, the visible vaginal mucosa of tissue slice has slight damaged, visible telangiectasis has a small amount of neutrophil infiltration in the submucous tissue in the tissue.
Invalid: vaginal mucosa hyperemia, redness, rough surface, the purulent secretion that a large amount of white bean curd slag specimens and wire drawing shape are arranged, visible a large amount of Candida albicans of vaginal smear microscopy and exfoliative cyte, the visible vaginal mucosa of tissue slice has the damage of damaged property, visible a large amount of telangiectasis have a large amount of neutrophilic granulocytes and macrophages infiltration in the submucous tissue in the tissue.
The therapeutical effect of the rabbit colpitis mycotica treatment that table 12 pair Candida albicans causes
The result: suppository group of the present invention and FUYANPING SHUAN group have the obvious treatment effect to the rabbit colpitis mycotica that Candida albicans causes, along with dosage increases, it strengthens the colpitis mycotica therapeutical effect.Suppository group of the present invention is stronger to the therapeutical effect of rabbit colpitis mycotica than FUYANPING SHUAN group.
Ten, to the morphologic influence of experimental rat cervical erosion pathology
60 of healthy adult SD female rats, body weight 200～220g, no pregnant, be divided into 6 groups at random, 10 every group, matched group and model group are given the equivalent normal saline; FUYANPING SHUAN group dosage is 0.32g crude drug/kg; Suppository group of the present invention administration little, in, heavy dose is respectively 0.08,0.16,0.32g crude drug/kg.(2,000,000,000/ml) insert the people to cervix uteri (uterus subangle place) with syringe (needle point polishes) from vagina to each treated animal, inject every rat 0.2ml back and forth several times after the repeated friction with golden Portugal bacterium liquid except that matched group.When daily same method and dosage reproduce mould once.3d inserts the people to the cervix uteri administration with syringe (needle point polishes) from vagina after the modeling, every day 1 time, 10d continuously.11d after the administration puts to death each treated animal, dissects the taking-up vagina and organizes to uterus subangle place, put in 20% formalin solution and fix, do the routine paraffin wax section, HE dyeing, the following vagina of observing of mirror is to uterine cancer cell morphological change and mucosa, and the morphologic inflammation of matter changed degree between mucosa was following.See Table 13
Standards of grading:
Inflammatory infiltration: a matter is dispersed in neutrophilic leukocyte or lymphocyte, remembers 1 fen; Neutrophilic leukocyte is showed increased around blood vessel, remembers 2 fens; In most visuals field more inflammatory cell is arranged, but do not have obvious necrosis and calcification, remember 3 fens; Tangible abscess or calcification are arranged, remember 4 fens.
The mucosal epithelium hypertrophy: simple columnar epithelium has apocrine secretion, remembers 1 fen; Columnar epithelium has apocrine secretion, remembers 2 fens; Squamous epithelial cancer occurs, but the level of squamous epithelial cancer is less, remembers 3 fens; The squamous epithelial cancer level increases, and fall into disarray or keratinization is arranged is remembered 4 fens.
Rotten to the corn edema: slight rotten to the corn edema is arranged, remember 1 fen; Rotten to the corn edema is obvious, remembers 2 fens; Rotten to the corn edema involves the muscle shallow-layer, remembers 3 fens; Rotten to the corn edema involves the muscle deep layer, remembers 4 fens.
The table 13 pair morphologic influence of experimental rat cervical erosion pathology (x ± s)
Compare * *＜0.01 with model group; With the FUYANPING SHUAN group than zero P＜0.01.
The result: suppository group of the present invention and FUYANPING SHUAN group have significant protection and improvement effect to rat cervical erosion due to the golden Portugal bacterium, have compared significant difference with model group.Suppository group of the present invention has been compared significant difference with the FUYANPING SHUAN group.Suppository group of the present invention is stronger than the effect of FUYANPING SHUAN group treatment experimental rat cervical erosion.
Acute toxicity testing is the result show: in the suppository 24h of the present invention to the continuous vagina administration of mice 3 times, each 4h at interval, accumulation medicine total amount reaches 6g crude drug/kg, is 237 times of clinical people's consumption.Mice is movable normal behind the administration 7d, animal skin gloss, and mouth and nose do not have secretions, do not have diarrhoea and take place.There is not 1 dead mouse.8d puts to death every mice perusal heart of back dissection, liver, spleen, lung, kidney, brain, thymus, adrenal gland, ovary, uterus, stomach, intestinal etc. and does not all find color and paramophia.Show that suppository group of the present invention do not have acute toxic reaction.
Long term toxicity test is the result show, the basic, normal, high dosage of suppository group of the present invention is respectively 0.5,1.0,2.0g crude drug/kg/d, be equivalent to 19.7,39.5,79.0 times of clinical dosage, compare with matched group behind vagina administration 90d and the drug withdrawal 14d, the general situation of rat, hematology, blood biochemical are learned, electrocardiogram does not all have tangible influence, the yet no abnormal pathological change of system's dissection, organ coefficient and histopathological examination.So suppository of the present invention in long term toxicity test, is not found overt toxicity reaction and delayed toxicity reaction.As seen, the following rat vagina administration of 2.0g crude drug/kg/d is a safe dosage.
Conclusion: the mice auricle swelling due to suppository group of the present invention and the FUYANPING SHUAN group xylol, the granuloma due to the embedding cotton balls, the rat paw edema that carrageenin causes have significant antagonism; Can significantly improve histamine phosphate and cause the itch-threshold of itching and reacting; The Mice Auricle microcirculation there is the effect of remarkable expansion caliber; Can reduce the number of times of mouse writhing; Rat experiment temper cervicitis disease there is the obvious suppression effect; Rat cervical erosion due to the golden Portugal bacterium there are significant protection and improvement effect; Extracorporeal bacteria inhibitor test shows that staphylococcus aureus, escherichia coli, Candida albicans, pseudomonas aeruginosa, Bacillus subtillis are had bacteriostasis; The rabbit bacterial vaginitis that staphylococcus aureus, escherichia coli, pseudomonas aeruginosa mixed infection are caused has therapeutical effect; Inhibited to the mice subcutaneous abscess that trichomonal vaginitis causes; The rabbit colpitis mycotica that Candida albicans is caused has the obvious treatment effect.Test shows, suppository group of the present invention is than the anti-inflammation detumescence of FUYANPING SHUAN group, antipruritic, analgesia, microcirculation improvement, antibiotic and strong to bacillary, mycotic, trichomonal vaginitis, cervical erosion therapeutical effect, illustrated clinically, suppository of the present invention is used for damp invasion of lower energizer than FUYANPING SHUAN, leucorrhea with red and white discharge, the pudendal pruritus swelling of the vulva, and the therapeutic effect of the vaginitis that causes of antibacterial, mycete, infusorian, vulvitis, cervical erosion is good.
Clinical practice of the present invention:
Case one: * * * patient, 35 years old, be diagnosed as colpitis mycotica, mainly show as frequent micturition, leucorrhea has the abnormal flavour symptom, through continuous external suppository of the present invention after course of treatment, the frequent micturition transference cure, the abnormal flavour of leucorrhea symptom obviously alleviates, after continuing medication two courses of treatment, symptom all disappears, and chemical examination is fully recovered on inspection.
Case two: * * patient, 45 years old, be diagnosed as bacterial vaginitis, mainly showing as frequent micturition, pudendal pruritus, causalgia, leucorrhea with red and white discharge, leucorrhea has the abnormal flavour symptom, through external suppository of the present invention continuously after course of treatment, and frequent micturition, causalgia transference cure, pudendal pruritus, leucorrhea with red and white discharge, leucorrhea have the abnormal flavour symptom obviously to alleviate, after continuing medication course of treatment, symptom all disappears, and chemical examination is fully recovered on inspection.
Case three: * * * patient, 38 years old, be diagnosed as cervicitis, mainly show as frequent micturition, urgent micturition, stomachache, and with the leucorrhea secretion increasing, through continuous external suppository of the present invention after three courses of treatment, frequent micturition, dysurea transference cure, leucorrhea secretion is normal, continue medication two courses of treatment after, symptom all disappears, and chemical examination is fully recovered on inspection.
The specific embodiment of the invention:
Suppository prescription proportioning of the present invention:
Radix Sophorae Flavescentis 500g Margarita layer powder 5g dried Alumen 100g
Ramulus Et Folium Picrasmae 400g Fructus Cnidii 400g berberine hydrochloride 40g
Mentholum 4g Borneolum Syntheticum 10g boric acid 60g
Fructrs Hippophae seed oil 250ml mixed fatty glycerides 1200g
The preparation method of suppository of the present invention:
Get Margarita layer powder, berberine hydrochloride, dried Alumen, boric acid and be ground into fine powder, sieve, standby.Other gets Fructus Cnidii and is ground into fine powder, crosses 100 mesh sieves, and is standby.Get each secondary of 80% alcohol heating reflux that Radix Sophorae Flavescentis, Ramulus Et Folium Picrasmae branch add 6 times of amounts, each 2 hours, filter merging filtrate, decompression recycling ethanol (0.08Mpa, 65～70 ℃) filtrate is concentrated into relative density 1.17-1.21 (60 ℃), and drying is ground into fine powder, add above-mentioned fine powder, mix homogeneously sieves.Borneolum Syntheticum, Mentholum are ground into fine powder are dissolved in mixing in the Fructrs Hippophae seed oil, standby.The mixed fatty glycerides heating is made fusing, filter, behind the Fructrs Hippophae seed oil mixing, in 40-50 ℃ of insulation, add medicated powder, mixing makes 1000 of bolt grains.
Claims (2)
1. suppository that is used for the treatment of gynaecopathia is characterized in that it is to be made by the following weight proportion raw material:
Radix Sophorae Flavescentis 500g Margarita layer powder 5g dried Alumen 100g
Ramulus Et Folium Picrasmae 400g Fructus Cnidii 400g berberine hydrochloride 40g
Mentholum 4g Borneolum Syntheticum 10g boric acid 60g
Fructrs Hippophae seed oil 250ml mixed fatty glycerides 1200g.
2. according to the preparation method of the described suppository of claim 1, it is characterized in that: get Margarita layer powder, berberine hydrochloride, dried Alumen, boric acid and be ground into fine powder, sieve, standby; Other gets Fructus Cnidii and is ground into fine powder, crosses 100 mesh sieves, and is standby; Get each secondary of 80% alcohol heating reflux that Radix Sophorae Flavescentis, Ramulus Et Folium Picrasmae add 6 times of amounts respectively, each 2 hours, filter, merging filtrate, decompression recycling ethanol ,-0.08Mpa, under 65～70 ℃ the condition, the relative density that records when being concentrated into 60 ℃ is 1.17-1.21, drying is ground into fine powder, adds above-mentioned fine powder, mix homogeneously sieves.Borneolum Syntheticum, Mentholum are ground into fine powder are dissolved in mixing in the Fructrs Hippophae seed oil, standby; The mixed fatty glycerides heating is made fusing, filter, behind the Fructrs Hippophae seed oil mixing, in 40-50 ℃ of insulation, add medicated powder, mixing makes 1000 of bolt grains.
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| CN101991605B (en) * | 2010-11-12 | 2011-12-07 | 杨长辉 | Medicament for bactriostasis, protection and cleaning of vagina of human body and preparation method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN102526139A (en) * | 2012-02-23 | 2012-07-04 | 华子昂 | Artificial vaginal solution and preparation method thereof |
| CN105477489A (en) * | 2014-05-15 | 2016-04-13 | 刘善奎 | Preparation method of suppository for treating cervical hypertrophy |
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| CN1559577A (en) * | 2004-03-05 | 2005-01-05 | 毛友昌 | Suppository for treating gynecological inflammation and its preparation method |
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